Elastomeric closures such as stoppers and reseals are commonly used to seal various medical solution containers. For example, elastomeric stoppers are used to close small volume drug vials. Similarly elastomeric reseals are used to close the ports of flexible plastic IV solution bags.
Currently a sharp access device such as a syringe needle or a piercing pin must be used to penetrate the elastomeric closure to permit access to the solution in the sealed container. Conventionally, the elastomeric closures have thick dimensions to permit resealing after penetration and withdrawal by a sharp access device, to withstand distortion during sterilization and to prevent degradation of the solution during transit and storage. The resiliency of the elastomer and the thick dimensions thus require that a sharp access device such as a syringe needle or a piercing pin be used to penetrate the closures.
With increasing concern about diseases such as HIV and AIDS, which are carried by bodily fluids, the use of "sharp" devices in the healthcare environment is being minimized. Sharps have the potential to breach the skin barrier by an "accidental stick" and thereby potentially transmit disease. It is estimated that more than one half of the sharps currently used in hospitals are used only for fluid transfer and connection involving IV administration sets. These sharp "connectors" are being replaced by blunt cannula and pre-pierced reseals such as the Lifeshield.RTM. Blunt Cannula and the Lifeshield.RTM. Pre-pierced Reseal, both sold by Abbott Laboratories.
Currently, however, when a drug is withdrawn from a vial or added to an IV solution bag for example, a sharp needle syringe or piercing pin must be used. The majority of elastomeric closures for standard drug vials or IV solution bags currently in use cannot be readily pierced by a blunt entry devices such as the LifeShield.RTM. Blunt Cannula. Thus, many "sharp" devices remain in use.
Recent concerns about these other potential accidental sticks has led to an effort to reduce the need for healthcare providers to use sharp needles and/or pins for access to drug vials and solution bags. For example, vial adapters have been introduced to shield the healthcare provider from the sharp access devices needed to penetrate the vial stopper. The other end of the vial adapter may include a standard luer connector, or, as disclosed in U.S. Pat. No. 5,100,394 to Dunbar, et al. titled, "Pre-Slit Injection Site", a pre-slit septum compatible with a blunt cannula entry device. However, many healthcare workers and providers are reluctant to use the available vial adapters since the vial adapters increase the time for set-up and change-over, created additional waste material for disposal and added additional expense.
Thus, it is an object of the present invention to provide a simplified adapter that is directly usable with a blunt entry devices for fluid access through the most commonly used thick elastomeric closures such as the stoppers on standard drug vials.
It is another object of the present invention to provide a blunt cannula adapter which is economical to manufacture and easy to use.
It is another object of the present invention to provide an adapter which readily indicates that the adapter has been previously used.
Another object of the present invention is to provide an adapter which does not require undue force by the health care provider to insert the blunt entry device and adapter through an elastomeric closure, while still protecting the user from accidental stick and the adapter from touch contamination.
Other important objects of the present invention will become readily apparent from the following description and drawings.